Study Start Up Specialist

Job description

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The PositionAt Roche Pharma Product Development Global Clinical Operations (PDG), we are determined to transform drug development and realize our Pharma Ambition to deliver 20 transformative medicines addressing diseases with the highest societal burden by 2029. As a key member of our Country Clinical Operations Study Start-Up team, your primary focus is to drive and facilitate efficient study start-up processes to contribute to the delivery of clinical trials to patients. You will enable innovative clinical trial delivery, address study start-up needs across various therapeutic areas, and ensure seamless trial execution for patients, investigators, and clinical site staff. Collaboration with local country teams, global study teams, and CROs is essential to this role. The Role This role focuses on the efficient and compliant initiation of Roche-sponsored clinical trials by executing effective start-up strategies while maintaining regulatory compliance. Additionally, this role involves managing amendments throughout the study lifecycle. You will bring subject matter expertise and may work cross-functionally in the following areas: Study Start-Up Strategy & Execution: Support and execute study start-up strategies for faster site activations, collaborating with internal and external teams, CROs, and sites. Budgeting & Contract Management: Assist with clinical site budget strategies and contract negotiations, and manage execution (including confidentiality agreements, indemnity, and protocol amendments). Collaborate with internal/external partners on financial/legal compliance, and maintain accurate contract data in relevant systems to support effective planning. Payment Oversight: Assist in overseeing site payments, escalations, and reporting via shared service centers and incompliance with site contracts. Help ensure financial/regulatory compliance for local operations. Participate in accrual/purchase order planning and reconciliation. Clinical Trial Submissions & Regulatory Coordination: Support and execute submission packages for regulatory bodies and health authorities. Assist in responding to RFIs and ensure timely document submission to the TMF. Track submissions in relevant systems and stay updated on regulatory requirements. Who You AreYou have a degree (MD, PhD, MA/MS, BA/BS) in life sciences or a related field. A postgraduate degree is highly desirable. You have practical operational experience in clinical trial start-up, regulatory submissions, and cross-functional collaboration. You possess a strong understanding of ICH-GCP, EU CTR, and local regulatory environments. You have excellent communication, interpersonal, and problem-solving skills, with a collaborative mindset. You are fluent in both written and spoken English, and in the language(s) of the host country. Who we areA healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. Roche is an Equal Opportunity Employer.